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EC number: 947-850-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- key study
- Justification for type of information:
- see category justification attached to chapter 13
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other:
- Remarks:
- Source: EC 701-177-3, Schill+Seilacher, 2009, LAUS, 09070901G701, activated sludge
- Duration:
- 3 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- 130 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other:
- Remarks:
- Source: EC 701-177-3, Schill+Seilacher, 2009, LAUS, 09070901G701, activated sludge
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other:
- Remarks:
- Source: EC 701-177-3, Schill+Seilacher, 2009, LAUS, 09070901G701, activated sludge
- Duration:
- 3 h
- Dose descriptor:
- IC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks on result:
- other:
- Remarks:
- Source: EC 701-177-3, BASF, 1989, Ciba Geigy, 894071, activated sludge
- Duration:
- 3 h
- Dose descriptor:
- other: IC20
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks on result:
- other:
- Remarks:
- Source: EC 701-177-3, BASF, 1989, Ciba Geigy, 894071, activated sludge
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Sep 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Version / remarks:
- adopted in 1984
- Deviations:
- yes
- Remarks:
- Higher temperature during the test (Guideline: 18 - 20 °C, Test: 23.3 - 24.4 °C)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.11 (Biodegradation: Activated Sludge Respiration Inhibition Test)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution containing 10 g/L was prepared using the following procedure: 10 g test item was mixed with 1.1 g NaOH (45%). 40 mL deionised water (80 – 100 °C) was added. After homogenisation with a glass stirrer, 85 mL deionised water (room temperature) was added. Then, the vessel was stirred on a magnetic stirrer. 0.5 M NaOH was added until the resulting solution was clear. The pH of the solution was adjusted to 7.8 ± 0.2 with 1 M HCl. the solution was transferred into a volumetric flask and filled up to 1000 mL with deionised water. - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Source of the inoculum: The sludge was taken from the activation basin of the sewage plant in Edenkoben, Germany
- Laboratory culture: Upon arrival, the sludge was washed with tap water three times, centrifuged and resuspended in tap water.
- Suspended solids: 4.2 g/L - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- pH:
- 7.7 - 8.1
- Nominal and measured concentrations:
- Nominal: 0, 1.0, 3.2, 10, 32, 100, 320, 1000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Beakers
- Material, fill volume: Glass, 500 mL
- Aeration: Purified air at 0.75 L/min
- No. of vessels per concentration (replicates): 2 for treatment 1000 mg/L, 1 for all other treatments and positive control
- Concentration of suspended solids: 1.7 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water
- Total organic carbon: < 1.0 mg/L
- Metals (mg/L): Na 4.7, K 2.6, Ca 33.1, Mg 2.1, other metals < 0.0005 to < 0.01
- Pesticides: < LOD
- Chloride: 9.0 mg/L
- Conductivity: 189 µS/cm
- Intervals of water quality measurement: pH was measured at test end.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
- Respiration rate was measured after 3 h of incubation
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2 - Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dichlorophenol
- Duration:
- 3 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- 130 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other: 95% CL = 62 - 310 mg/L
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other: 95% CL = 480 - 7200 mg/L; extrapolated
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Details on results:
- - The inhibition caused by the test item did not rise above 45%. Therefore the EC50(3h) was determined by extrapolation.
- All validity criteria are fulfilled. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: 9.1 mg/L, 95% CL = 7.2 - 11.0 mg/L - Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 08 Mar 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Version / remarks:
- adopted in 1984
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item was directly added to the test medium. - Test organisms (species):
- activated sludge
- Details on inoculum:
- - Source of inoculum: Activated sludge was collected from the sewage treatment plant of Therwil, Switzerland on 06 Mar 1989.
- Preparation of inoculum for exposure: The sludge was separated from the aqueous layer by settling. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Test temperature:
- 18 - 20 °C
- Nominal and measured concentrations:
- Nominal: 0, 1.1, 3.3, 10.7, 32.0, 100.2 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: BOD flasks with gas inlet
- Size, fill volume: 250 mL, 200 mL
- Aeration: Yes
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2
- Concentration of sludge: 1.6 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated drinking water
EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
- Microbial respiration was measured after 3 h of incubation.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: approx. 3.2 - Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dichlorophenol
- Duration:
- 3 h
- Dose descriptor:
- other: IC20
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Duration:
- 3 h
- Dose descriptor:
- IC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Details on results:
- - Validity criteria are fulfilled.
- Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Relevant effect levels: IC50 = 13 mg/L
Referenceopen allclose all
Table 1: Inhibition (%) of microbial respiration after 3 h of incubation
Concentration |
% Inhibition |
Control |
- |
1.0 |
-3.2 |
3.2 |
1.2 |
10 |
1.7 |
32 |
16.9 |
100 |
25.5 |
320 |
24.0 |
1000 (1) |
43.8 |
1000 (2) |
45.3 |
Table 1: Inhibition of microbial respiration
Concentration (mg/L) |
Consumption Rate (mg/L*h) |
Inhibition (%) |
Blank 1 |
40.62 |
2 |
Blank 2 |
42.21 |
-2 |
1.1 |
41.62 |
0 |
3.3 |
43.97 |
-6 |
10.7 |
41.79 |
-1 |
32.0 |
35.70 |
14 |
100.2 |
30.00 |
28 |
Description of key information
NOEC (3 h) = 10 mg/L (OECD 209, activated sludge); read-across
Key value for chemical safety assessment
Additional information
No studies investigating the toxicity to microorganisms are available for Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7). Therefore, in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) was conducted.
The chemical properties of the target and source substance are similar due to the structural similarities, i.e., sarcosine head group and the hydrocarbon tail. In addition, due to the pka of the target substance (pKa = 3.96, major constituent), at physiological pH values (above 6) the target substance is expected to be in the anionic form, as are the source substances. As a result, the chemistry of the target and source substance, in solution (above pH 6), are expected to be similar. Thus, the source substance is considered suitable representative for the evaluation of the toxicity to microorganisms of the target substance. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.
The key study conducted with the source substance N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) was carried out under GLP conditions according to OECD guideline 209. Effects on the respiration rate of microorganisms were observed at concentrations of 32 mg/L and above (nominal), leading to an estimated EC50 (3 h) of 1300 mg/L (extrapolated) and a NOEC (3 h) of 10 mg/L.
The supporting study conducted with the source substance N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) according to OECCD guideline 209 did not follow GLP standards. Five test concentrations (1.1, 3.3, 10.7, 32.0, 100.2 mg/L) were inoculated with activated sludge. In this study, the IC50 (3 h) for respiration inhibition was above the highest tested concentration of 100 mg/L.
Based on the available results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a comparable structure and chemistry, it can be concluded that Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7) will exhibit comparable effects on activated sludge microorganisms.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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